FTC headquarters in Washington DC

Happy Thanksgiving for GSK with FTC approval of Novartis vaccine biz

27-Nov-2014 - Just in time for the holidays, GSK can ‘give thanks’ to the US Federal Trade Commission (FTC) which has approved the $7bn acquisition of Novartis’ vaccine business.

Gabapentin capsules were distributed with no contents (Picture: Bill Brooks)

Aurobindo recalls empty epilepsy capsules

27-Nov-2014 - Aurobindo Pharma has recalled one lot of Gabapentin for the treatment of epilepsy and postherpetic neuralgia (pain after shingles), after it was found to contain empty capsules.

Recipharm is buying Flamel's manufacturing facilitynear Bordeaux, France

Recipharm adds French plant and drug delivery tech in strategic deal with Flamel

27-Nov-2014 - Recipharm will acquire a facility and add technologies including spray granulation and spray coating as part of a “truly strategic” collaboration with France-based Flamel Technologies. 

Inside a Dr Reddy's API facility

Dr Reddy's API plant receives USFDA 483 with nine observations

27-Nov-2014 - Dr Reddy’s says an API plant in India is unlikely to be subject to further regulatory enforcement after receiving a US FDA 483 with nine observations.

An Ebola response worker in Sierra Leone. (Picture: European Commission DG ECHO)

US politicians plan fast-track vouchers to reward Ebola R&D

26-Nov-2014 - Bipartisan bills introduced in the US House of Representatives and the Senate would give manufacturers of Ebola therapies vouchers to speed up review of a drug of their choice.

Merck's plant near Panaji, Goa.

Why cashews and coconuts are Merck's green energy secret

26-Nov-2014 - Merck KGaA will run its manufacturing plant in Goa on fuel from cashews and coconuts.

Chinese excipient market set to more than double by 2017

Chinese excipient market set to more than double by 2017

26-Nov-2014 - With more than 90 excipient manufacturers in China dedicated to the pharma industry, the country expects its output of excipients to more than double to about $8.9bn (€7.1bn), according to a new report.

Non-executive boards: who should fill the seats?

Diversity in pharma: why ‘risk minimisation’ has it all wrong

25-Nov-2014 - The lack of women on pharma boards is well-known, so why are companies still slow to balance the genders? A recruiter tells us the problem is “demand, not supply” and why quotas aren't a simple fix.

EMA adopts guidelines on phthalate excipients, cross-contamination

EMA adopts guidelines on phthalate excipients, cross-contamination in manufacturing

25-Nov-2014 - The two guidelines offer help to manufacturers looking to use potentially hazardous phthalates as excipients in drugs, as well as those that have shared facilities where multiple drugs are produced.

Lundbeck is now searching for a new leader. (Picture: Flickr/Dan Peluska)

Ousted: rule-breaking Lundbeck CEO and Novartis scientist get the boot

25-Nov-2014 - Two pharma giants are today looking for new employees after pushing out the CEO of Lundbeck and a Novartis researcher for rule-breaking.

The sterile injectable plant is back in business

AMRI re-opens troubled sterile injectable facility in New Mexico

25-Nov-2014 - AMRI’s Albuquerque, New Mexico sterile injectable facility has resumed full manufacturing operations following an environmental deviation. 

Hamburg getting cozy with a Chinese official

US, Chinese regulators forge closer ties as FDA looks to triple staff

24-Nov-2014 - As FDA commissioner Margaret Hamburg wraps up her trip in China it looks like the FDA is creating a stronger bond with its Chinese counterparts as the FDA looks to triple its staff there.

Compounding pharmacies can choose to register with the FDA. (Picture: Flickr/William Warby)

$15k and API info: FDA releases guide to registering drug compounders

24-Nov-2014 - The US Food and Drug Administration (FDA) is encouraging hospitals to purchase their compounded drugs from organisations registered as outsourcing facilities, and has issued guidance on accreditation.

Johnson Matthey: APIs down in first half 2014/5

Johnson Matthey: APIs down but Sigma-Aldrich acq could bring opportunities

24-Nov-2014 - The acquisition of Sigma-Aldrich by Merck KGaA could provide some opportunities for Johnson Matthey, the fine chemical company says as it reports a flat first half 2014/15.

Brattvåg, Norway - BASF divests its medium concentrate omega-3 production plant

BASF sells Norway plant, focuses on pharma grade omega-3 products

24-Nov-2014 - BASF says the supply of API to GSK and other pharma customers will not be affected by the divestment of an omega-3 production plant in Norway.

Does Sanofi have a replacement CEO in its sights?

Does Sanofi have a replacement CEO in its sights?

24-Nov-2014 - Plus the latest drug industry hirings, firings and awards in this week's column.

The EMA's Adaptive pathway could help speed up the approval process

EMA: New pathways and Ebola vaccines can help expedite approvals

20-Nov-2014 - The EMA is “caught between a rock and a hard place” in expediting drug development, but an agency Executive says change can come through its new adaptive licensing pathway.

FT conference in London on Tuesday. George Freeman outlined plans to accelereate drug development process

UK Hospitals to play part in Gov efforts to speed clinical trial process

20-Nov-2014 - UK life sciences minister George Freeman wants hospitals to play more of a role in clinical trials and says accelerating the drug development process in the post block-buster era is key for Big Pharma and patients.

MHRA says quality system deficiencies are most common issue

MHRA says quality system deficiencies are most common issue from inspections

20-Nov-2014 - Deficiencies related to manufacturers’ quality systems are by far the most prevalent issue cited from inspections by the UK’s MHRA (Medicines and Healthcare Products Regulatory Agency), the agency said in a report on 2013 inspections.

A photo of the fraudulent product

US FDA calls out two companies over fake Ebola treatments

20-Nov-2014 - The US FDA and the Federal Trade Commission have sent warning letters to two companies claiming to have drugs that treat Ebola though no such product has been approved by the agency.